Institute of Biophysics/Biomathematics - IBILI, Faculty of Medicine, Coimbra University, Portugal.
Adv Drug Deliv Rev. 2011 Jun 19;63(7):547-54. doi: 10.1016/j.addr.2010.09.015. Epub 2010 Oct 8.
Molecular imaging techniques are increasingly being used as valuable tools in the drug development process. Radionuclide-based imaging modalities such as single-photon emission computed tomography (SPECT) and positron emission tomography (PET) have proven to be useful in phases ranging from preclinical development to the initial stages of clinical testing. The high sensitivity of these imaging modalities makes them particularly suited for exploratory investigational new drug (IND) studies as they have the potential to characterize in vivo pharmacokinetics and biodistribution of the compounds using only a fraction of the intended therapeutic dose (microdosing). This information obtained at an early stage of clinical testing results in a better selection among promising drug candidates, thereby increasing the success rate of agents entering clinical trials and the overall efficiency of the process. In this article, we will review the potential applications of SPECT imaging in the drug development process with an emphasis on its applications in exploratory IND studies.
分子成像技术在药物开发过程中越来越多地被用作有价值的工具。基于放射性核素的成像方式，如单光子发射计算机断层扫描（SPECT）和正电子发射断层扫描（PET），已被证明在从临床前开发到临床测试的初始阶段都非常有用。这些成像方式的高灵敏度使它们特别适合探索性新药研究（IND），因为它们有可能仅使用治疗剂量的一小部分（微剂量）来描述化合物的体内药代动力学和生物分布。在临床测试的早期阶段获得的这些信息可以更好地选择有前途的候选药物，从而提高进入临床试验的药物的成功率和整个过程的效率。在本文中，我们将回顾 SPECT 成像在药物开发过程中的潜在应用，重点介绍其在探索性 IND 研究中的应用。
